Pegylated Liposomal Doxorubicin (Doxil) With Rituximab in Relapsed AIDS-Related Non-Hodgkin's Lymphomas

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

A Pilot Phase II Study of Pegylated Liposomal Doxorubicin (Doxil) With Rituximab in Relapsed AIDS-Related Non-Hodgkin's Lymphomas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00183976
• Other study ID #: 17NHL-03-2
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: May 20, 2014
• Start date: April 2005
• Est. completion date: January 2006

Study information

• Verified date: May 2006
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is for patients who have been treated before and either the treatment did not work or the lymphoma has come back.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 2006
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically documented B-cell non-Hodgkin's lymphoma [NHL] (diffuse mixed, diffuse or follicular large B-cell, immunoblastic), Burkitt or Burkitt-like lymphomas, and primary effusion lymphomas.

• Seropositive for HIV by any approved test (prior documentation of HIV seropositivity is acceptable).

• Failed or relapsed after at least 1 prior chemotherapy treatment (chemotx) regimen but could have had no more than 2 prior chemotx regimens with only one of them being an anthracycline-containing regimen. Prior treatment (tx) with rituximab allowed.

• All stages of disease

• Measurable or evaluable tumor

• Greater than or equal to 18 years of age

• Karnofsky performance status greater than 50%

• Absolute granulocyte count (AGC) greater than 1.0; platelets greater than 75,000; hemoglobin (Hgb) greater than 8.0 (unless these parameters are abnormal secondary to lymphomatous involvement of marrow, or due to HIV-related thrombocytopenia).

• Bilirubin less than 2.0 (unless elevated secondary to lymphomatous involvement of liver or biliary system or due to other HIV-related medications such as Crixivan).

• Creatinine less than 2.5 or creatinine clearance greater than 60 ml/min

• Multigated acquisition (MUGA) scan or 2D echocardiogram indicating left ventricular ejection fraction (LVEF) greater than or equal to 50% within 42 days prior to first dose of study drug.

• Patients with central nervous system (CNS) involvement are eligible provided that systemic lymphomatous disease is also present.

• Concurrent therapy for HIV with any licensed agent or an agent available on an expanded access program will be required.

• Signed informed consent including Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization.

Exclusion Criteria:

• Acute intercurrent infection that may interfere with planned protocol. Patients with mycobacterium avium are not excluded. Chronic therapy with potentially myelosuppressive agents is allowed provided that entry hematologic criteria are met.

• Second active tumor. Patients with non-melanomatous skin cancer, in-situ cervical cancer, or Kaposi's sarcoma, not requiring systemic chemotherapy may be entered on study.

• Primary CNS lymphoma.

• Documented history of congestive heart failure (CHF), hemodynamically unstable arrhythmia, myocardial infarction (MI) in the preceding 6 months, or evidence on electrocardiogram (EKG) of untreated cardiac ischemia.

• Prior exposure to a liposomal anthracycline (liposomal doxorubicin or daunorubicin) for the treatment of lymphoma. Prior exposure to conventional doxorubicin allowed.

• Prior radiation therapy within 4 weeks, unless for emergency conditions secondary to lymphoma (i.e., CNS tumor, cord compression)

• Prior systemic chemotherapy or biologic therapy within 3 weeks

• History of hypersensitivity reaction to anthracyclines or granulocyte colony-stimulating factor (G-CSF)

• History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride (HCl)

• Investigational agent(s) within 4 weeks of start of study therapy.

• History of cardiac disease with New York Heart Association (NYHA) greater than or equal to Class II, or clinical evidence of CHF

• Pregnant or nursing mothers.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burkitt Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma
• Primary Effusion Lymphomas

Intervention

Drug:
• Pegylated Liposomal Doxorubicin (Doxil) and Rituximab

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States,